Careers Chamblee 2016 05 15 RAPS

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May 2015
5/26/2016© Andrea Chamblee 2016 1
Andrea Chamblee, Esq., RAC
Regulatory Affairs Careers

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Disclaimer
These materials were written and
prepared by the author
in her private capacity.
No official support or endorsement by
the Food and Drug Administration
is intended
or should be inferred.
Bio:
 Certified Regulatory Affairs Professional (RAC)
1993; First class of RAPS Fellows 2008.
 Experiences across all regulated products with an
emphasis on compliance, enforcement, and GxP.
 JHU and GWU Adjunct Professor; Keck Graduate
School lecturer.
 Member MD, DC bars. RAPS Executive
Development Program, Kellogg School,
Northwestern University 2008.

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The iconic Barbie went from fashion plate
to pilot…to veterinarian, pediatrician… to astronaut…military…
But there was no single clear career path for RA.

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RA is a career that evolved relatively recently,
driven by people from other disciplines who
were affected by the explosion of regulations
from the New Deal agencies, especially after
1970.
There was no single recognized pathway to
Regulatory Affairs, and in fact, the discipline
that a person studied before going into RA
was — and is — a valuable asset to
understanding and applying regulations.
People come to RA from a variety of areas
From a lab Another office in a company
Law
Graduate school RA
Medicine/clinical
Pharmacy
Engineering
None of the above

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The Skill set is varied.
As with Barbie, the necessary
accessories for an RA professional
have changed significantly over time.

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 Education – new degree programs
in RA
 Certification - Regulatory Affairs
Professionals Society (RAPS) has
multiple certifications
 Publications – write articles (you
get to interview newsmakers, stay
current, and get noticed!)
 Networking – keep up with colleagues,
companies, changes in rules and
policies
You can get there from
here.

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 Drug Information Association (DIA):
www.diahome.org
http://careercenter.diahome.org/jobs
 RAPS job bank and guide:
http://careerconnections.raps.org/
 PDA http://careers.pda.org/
 Food & Drug Law Institute/FDLI: www.fdli.org
FDLI’s Smartbrief www.smartbrief.com

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www.usajobs.gov/JobSearch/Search/GetResults?Keyword=FDA
www.diahome.org
http://careercenter.
diahome.org/jobs

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http://pda-jobs.jobtarget.com/jobseeker/search/results/

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http://regulatorycareers.raps.org/jobs/#/results/location=20993%2C500&resultsPerPage=12&noS
tem=false&titlesOnly=false&salary_open=false&showMoreOptions=false&sort=DISTANCE/1,true

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http://jobsearch.monster.com/search/?q=FDA-__28Food-and-Drug-
Administration__29&where=20993__2C-Silver-Spring__2C-MD

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 Look at the company websites
 Read the news and trade press
 Look at SEC.gov filings
◦ Are they anticipating a product launch?
 Check FDA websites
◦ Applications
◦ Warning letters
◦ Recalls
◦ Citizen petitions
http://www.cafepharma.com/

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http://www.glassdoor.com

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• PAREXEL International http://www.parexel.com/
• Quintiles Transnational Corp. http://www.quintiles.com/
• PPD Consulting http://www.ppdconsulting.com/
• ERA Consulting Group http://www.eraconsulting.com/
• Medical Device Clinical Services – MDCI www.mdci.com/
• Biologics Consulting Group http://www.biologicsconsulting.com/
• QPharma Corp http://www.qpharmacorp.com/
And too many more to count
The Manager, Regulatory Affairs will
serve as the primary regulatory
representative to Project Teams for
projects or products.
Provide guidance to Project Teams on
steps necessary to comply with newly
enacted regulations and guidelines.
Interact with Project Mangers at FDA.
Determine regulatory requirements for
clinical and pre-clinical submissions to
FDA for assigned investigational and
marketed products.
Review documents intended for
submission to FDA to assure
compliance with regulatory standards.
Provide oversight and effectively
manage any outsourced regulatory
submissions.
Conduct independent regulatory
research.
Requirements: Qualified candidate
possesses 2+ years regulatory
experience in the pharmaceutical
industry or equivalent.
Advanced degree. Working
knowledge of drug development
process (particularly INDs and
NDAs), drug laws, regulations,
guidelines, and regulatory
submissions. Good understanding
of FDA organization. Good oral and
written communication skills
including the ability to discuss
scientific/technical data and
regulatory requirements with senior
management and FDA personnel.
Knowledge of ICH guidelines on
preparation of clinical study
reports, investigator brochures.

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 Be mindful of the etiquette
http://jobsearch.about.com/cs/info
interviews/a/infointerview.htm

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• In person
◦ Dress for the occasion
◦ Use business cards
◦ Don’t use first names until you are invited
◦ Everyone has time for coffee (offer to pay)
◦ Honor timeframes – if you say you only want
15 minutes, STOP after 15 minutes.
(Let them invite you to take more of their time.)
• In correspondence
◦ Don’t always use email
◦ Use a complete signature (auto signature)
This money is a joke…

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Search USAjobs by agency: HHS>FDA
https://my.usajobs.gov/JobSearch/Search/AdvancedSearch
Example:
Consumer Safety Officer
Additional Duty Location Info: 1 vacancy - Rockville, MD
MAJOR DUTIES:
- Participate in the review & evaluation of evidence submitted for legal and
administrative actions for medical devices in support of recommendation to
Center for approval or disapproval of the action.
- Review, evaluate, and respond to a variety of inquiries involving FD&C Act.
Communicate current policies and/or the interpretation thereof or questions
regarding compliance activities of submissions.
- Plan, initiate, assign, and coordinate investigations of routine assignments
by the field office to follow-up on products incidents or problems.
SALARY RANGE: GS-7-13: 36,671.00 – 115,742 USD per year
Requirements
Degree: that included at least 30 semester hours in one or a
combination of the following: biological sciences, chemistry,
pharmacy, physical sciences, food technology, nutrition,
medical science, engineering, epidemiology, veterinary medical
science, or related scientific fields that provided knowledge
directly related to consumer safety officer work. The 30
semester hours can include up to 8 semester hours in
statistics, or course work that included the principles, theory,
or practical application of computers or computer
programming; OR
Combination of education and experience--courses consisting
of at least 30 semester hours in the fields of study described in
A above, plus appropriate experience or additional education.
AND

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Requirements (con’t)
One yr of specialized experience that has equipped you with the
particular knowledge, skills, and abilities to perform successfully the
duties of the position, and that is typically in or related to the work of the
position to be filled such as experience in managing projects and
communicating technical information. To be creditable, specialized
experience must have been equivalent to at least the GS-9 level in the
Federal Government. OR
Ph.D. or equivalent doctoral degree, if related OR
3 full years of related progressively higher level graduate education
leading to such a degree OR
Equivalent combinations of related graduate education and specialized
experience
Education completed in foreign colleges or universities may be used to meet the above
requirements if you can show that the foreign education is comparable to that received
in an accredited educational institution in the United States. It is your responsibility to
provide such evidence when applying.
Other considerations:
◦ “Year In Grade” requirements – identify your “grade”
 Even if you’re not in a government job now – best guess
 Education can substitute for experience
◦ Recent contracting out, “shared services” of HR means:
 HR has no experience or expertise in evaluating
substitutions of education for experience;
 HR has no experience or expertise in evaluating special
needs for scientific disciplines;
 hiring officer may never know your resume was submitted.
You may need to call, lobby, use “Polite Persistence”

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HOW YOU WILL BE EVALUATED:
You will be evaluated to determine if you meet the minimum
qualifications required; and on the extent to which your application
shows that you possess the knowledges, skills, and abilities
Associated with this position as defined below. When describing your
knowledges, skills, and abilities, please be sure to give examples and
explain how often you used these skills, the complexity of the
knowledge you possessed, the level of the people you interacted with,
the sensitivity of the issues you handled, etc.
1. Knowledge of appropriate administrative and technical review
processes in order to support multi-disciplinary
regulatory/scientific programs.
2. Ability to manage detailed projects.
3. Ability to communicate orally and in writing.
 Don’t limit your government job search by
job title.
◦ There is no Regulatory Affairs job title in FDA.
 Be careful before you state in your
application question/answers that
you have no experience.
◦ Are you sure? Are you already regulatory?

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 Can you take a course?
Easy after work seminars (local chapters)
 RAPS
www.raps.org/your-career/regulatory-career-
advancement-guide.aspx
 PDA
www.pda.org/MainMenuCategory/Chapters.aspx
 Day-long www.kgi.edu/Corporate-
Partnerships/Corporate-Education.html
 Week-long, semester-long?
 Seek a mentor?
 You can study independently:
◦ FDA website www.fda.gov/Training
 FDA Tour
www.eduneering.com/fileadmin/user/Multi-
Media/FDA_demo_new/overview.htm
 CDRH Learn:
www.fda.gov/Training/CDRHLearn
 CDER Learn
www.fda.gov/Training/CDRHLearn

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You can study independently:
Books and articles
◦ Andrea’s wishlist on Amazon.com
www.amazon.com/registry/wishlist
/1P5281QAGYTJQ
◦ DIA:
www.diahome.org/en/Resources/
Publications/AboutPublications
◦ RAPS: www.raps.org
Attend, observe relevant meetings
 FDA advisory committee, other
meetings
◦ www.fda.gov/NewsEvents/Meetings
ConferencesWorkshops/
◦ www.fda.gov/AdvisoryCommittees/
Calendar/
4
65/26/2016© Andrea Chamblee 2016

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Set up a “Saved Search”

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Leave blank

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Recent Search Results

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After you attach your resume…
Fill out the personal information

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But I’m not an expert!
Are you sure?
 QC/Lab – you determine, perform, analyze testing, exclude
testing as appropriate. That is regulatory affairs.
• Legal – analyze and apply requirements of the law and
regulations, prevent violations. That is regulatory affairs.
• Manufacturing – determine, perform, analyze compliant
manufacturing procedures. That is regulatory affairs.
• Project management – meeting predetermined specifications.
• Writing, relationship building . That is regulatory affairs.

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If you are qualified, you will be referred to the selecting official.
If you are in the top 3 list of candidates, you should be interviewed

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Acrobat Document
Say Rational Approach Please-Rational Approach Please.
Can anyone relate? (raise your hand).
I’m late, I’m late for a very important date.
It’s been so long since I’ve had a date.
Can’t wait to integrate, collaborate, associate and commiserate.
Do we really need permission for our mission of
submissions without omissions? So what do you say- is
management on board to support this huge E-ffort?
Everything I know about being me- I learned in
kindergarten. Be nice to others. Stay in line. Don’t
push. Tell the truth. Don’t use bad language. Raise your hand if
it’s an emergency! Can anyone relate?
Oh--- yeah… (raise your hand). Mentor- Protector-
Confidant that’s what I want.
Hey Research…whassuppp?? What it is.
Can I believe it is what you want it to be…?
I’m not askin’ for much
Only that the data be con—firm—a –tor—y.

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Timeline, blame line, what’s my line? Gantt chart-
PERT chart - WHO art thou? Keep to the schedule- who makes
the schedule anyway?
Why, too bad, only 24 hours in a day.
Project team…what a scream! Sounds more like the Tower of
Babel. Who’s making all that rabble?
The language of technology is the key
but we’ll need a good translator to get this product out the
door –
then our stocks will really soar!
Case-by-case…science-based.
Science-based regulations.
We’re talking regulatory now not science.
Science is not compliance.
If no compliance can there be good science?
I trust in the Science…
And its collective intellect.
A legacy such as this… What’s not to respect?
We’re ready for the dossier. but we haven’t picked the dose- eh? What’s up
doc? Case-by-case it’s a race. BLA, NDA, PMA …
will all be prepared in a day. No way. Not in my day.
Control control-quality control. Is this a big black hole?
Or just out of control? Can’t wait – but need to validate. Specifications…
out of spec what the heck? Hit the deck.
It’s just that it’s hard to persuade those at FDA…
That the quality of the product is all that you say.
When the results we compile into the C of A…
Are not supported by a validated assay.
Knock knock. Who’s there? Let me in. Not by the hair o’my chinny chin chin
cuz I’m manufacturin.’
Then I’ll huff and I’ll puff and I’ll write you up –
for messin’ up and not compli- in’.
You’ll look for me when you get your 483.
Can any one relate? (raise your hand).
Don’t mean to be an obstacle
nor am I trying to be mean when I challenge your will.
Just facing the challenges to make our development plan accept-able. Over
and out….
A, B, C, D, E, F, GMP, GLP, GCP, GTP, GXP golly gee.
Are you listening to me? Are you listening to me?
We just got a consent decree. Now you’ll listen to me.
I’m finally –a VIP! And I’ll be able to RIP.
Can anyone relate? (raise your hand)

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Globalized, harmonized, standardized –
CTDs not to be confused with MTDs or STDs.
But it’s becoming contagious.
Even computerized.
Watch for those viruses.
Electronic submissions, remote data entry…
electronic signature-
but I can’t type with all this hype
Merge, but don’t get too hyper bout those links. Do you golf too?
We need to maintain a dialogue-
but dialogue don’t mean no-monologue plus monologue. What’d you say?
that you’re from the FDA
and you’re here today to help? Yeah!
We also said in God we trust everyone else bring the data. Let’s play the
Devil’s advocate-
but the Devil is in the details.
Did you say you were the FDA?
Is that what the D stands for?
Can anyone relate? (raise your hand)
Pediatric rule means kids are now cool.
Women in clinical trials too-
now you can’t be rude you gotta include -- not exclude
Orphan drugs for orphans-
do orphans really need all those drugs? Generics for much less…
I wanna be like Mike.
It’s-omics… genomics, pharmacogenomics, toxico- genomics,
pharmacotoxico-genomics, and metabon-omics, -and- icities…
immunotoxicity, repro- and carcino- genicity.
Serious AEs go to FDA, IRBs and DSMBs.
Rock’n and roll’n INDs are in.
Go fast track-Phase I/II /III-
but not so fast- we don’t know it all-
we got the phase IV- but...
now we’re being recalled. Can anyone relate? (raise your hand)
You can stay in bed - it's telemed –clinical trials in style for bad hair
days. Declaration of Helsinki has been the status quo… now being
revised –the question on the table is active or placebo.
Doctor, lawyer, Indian chief, patient’s rights are becoming more
important as they should be. Many are reaping the benefits from
patient advo -cacy.
CBER, CDER, CDRH- that’s where you go unless you don’t know
where to go then there are intercenter agreements –
combination products- product jurisdiction

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combination products- product jurisdiction. Whassup Ombudsman?
Have you seen the Budman?
Are you drinking? Ribbit ribbit. Can anyone relate? (raise your hand)
I’d walk a mile not to get a Refuse to File.
Clinical Hold I’m told is gonna hold up makin' all that gold. You need
a checklist… you can’t think? What are they thinking? You’re asking
if we do THIS will it be OK? It depends on what THIS is… What were
you thinking?
Create a new version to create a diversion with the new version. What
perversion? Risk sharing – sharing risk. It’s low- it’s mid- it’s high-
oh no- no go. Going going gone. Next in line…
Quality, Safety, Efficacy we have all three.
You should have enough copies.
I just planted 1000 trees. Can’t agree? OK so we go to advisory. How
many cell phones can you hide in one of these meetings anyway?
The final vote- 7 say yes and 6 say no. Big help to the FDA. Now
what? Can anyone relate? (raise your hand).
They were searchin’ for quite awhile
and finally found a new comish.
Did you get your wish?
Science, regulation and consumer protection.
It’s a huge responsibility
that is no longer free since MDUFMA, FDAMA… way to go mama!
I studied for the RAC and got my certif-i-cate
now I rate- hi 5!
Education- education not another degree.
Rah! Rah! The new RA Institute -now that’s for me.
Don’t be a jerk- you gotta network.
RAPS is a great professional society for a small fee-
congratulations are in order for reaching its’ 25th anniversary.
So stay involved- everyone counts. So who’s in? HANDS UP…
one, two, three… keep counting- It’s an important
COMMITMENT
that will make THE KEY DIFFERENCE in ensuring
the success of biologics, drug, and device development.
Sincerely yours…former Chair of the Board
and Madam President.
And that’s a RAP!October 2003
Dedicated to Rapper Jim Phelps, Esq.
for his 26 years of service as legal counsel
(first version presented at inaugural meeting of the
RAPS Baltimore/Washington Metro Area Chapter 3/2001)
Joy A. Cavagnaro, PhD, DABT, RAC
President. Access BIO
jcavagnaro@accessbio.com
( Chair of the Board, RAPS 2002) 2003©

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